Philips Easy Diagnost Classic x-ray system recall for switch defect
Philips Healthcare Inc. is recalling 12 Easy Diagnost Classic stationary x-ray systems because an incorrectly mounted inclination switch may fail to stop table tilting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a medical device that could lead to significant injury if the table tilts uncontrollably.
Plain-English summary
Philips Healthcare Inc. is recalling 12 units of the Easy Diagnost Classic stationary x-ray system (Catalog Numbers: 70642, 70643, 706030, 706031, 706032). The recall involves specific serial numbers: SN07000141, SN07000109, SN5000162, SN5000421, SN07000667, 200148, 200115, 200081, and 300114.
The recall is due to a defect where the inclination switch in the stand may have been mounted incorrectly. As a result, the switch could fail to stop the tilting movement of the table base due to hardware or software errors.
The affected units were distributed worldwide, including in the United States (IN, MA, MI, MO, NC, NY, PA, SC, and WI) and in Canada, Hong Kong, and New Zealand. Users should contact Philips Healthcare Inc. for instructions on how to address this issue.
The recalled product
- Product
- Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
- Manufacturer
- Philips Healthcare Inc.
- Affected units
- 12
Distribution
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